Trials · 2019
Influence of an exercise program on cardiac remodeling and functional capacity in patients with stroke (CRONuS trial): study protocol for a randomized controlled trial.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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da Silva Rodrigues Josiela Cristina, Luvizutto Gustavo José, da Costa Rafael Dalle Molle, Prudente Robson Aparecido, da Silva Taís Regina, de Souza Juli Thomaz, da Silveira Caroline Ferreira da Silva Mazeto Pupo, Rossi Daniele Andreza Antonelli, Winckler Fernanda Cristina, Modolo Gabriel Pinheiro, Valadão Tainá Fabri Carneiro, de Oliveira Antunes Letícia Cláudia, Martin Luis Cuadrado, Bazan Rodrigo, Bazan Silméia Garcia Zanati
Аннотация
BACKGROUND: Cardiovascular rehabilitation is one of the treatment options for post-stroke individuals in order to improve functional independence in activities of daily life and reduce energy expenditure. The aim of this trial is to evaluate the effect of an exercise program on the echocardiographic variables, functional capacity, inflammatory response, neurological status, nutritional status, cardiologic evaluation, and quality of life of patients after stroke.
METHODS/DESIGN: This is a randomized controlled trial including patients with ischemic stroke in the chronic phase. The patients will be evaluated at the beginning of the study and after 16 weeks. This will include clinical and physical evaluation, 6-min walk test, neurological assessment, nutritional assessment, ambulatory blood pressure monitoring, transthoracic echocardiography, and assessment of the quality of life. The sample size has been determined as 40 patients, who will be divided into two groups: control group (CG; n = 20) and intervention group (IG; n = 20). The CG will undergo conventional physiotherapy for 45 min, three times a week, up to 16 weeks, while the IG will be put on a cardiovascular rehabilitation program consisting of heating, aerobic exercise, and muscle strengthening for 45 min, three times a week, for 16 weeks. The primary endpoint will be functional capacity following a 6-min walk test (delta maxVO2) and morphofunctional echocardiographic variables (indexed left ventricular mass) before and after the intervention.
DISCUSSION: We expect to observe an improvement in cardiac structural and functional abnormalities in the IG, on echocardiography and biochemical examination, and that the improvement of these parameters after cardiovascular rehabilitation will have a favorable impact on the functional capacity and quality of life of patients after stroke.
TRIAL REGISTRATION: REBEC, RBR-4wk4b3. Registered on 19 September 2016.
METHODS/DESIGN: This is a randomized controlled trial including patients with ischemic stroke in the chronic phase. The patients will be evaluated at the beginning of the study and after 16 weeks. This will include clinical and physical evaluation, 6-min walk test, neurological assessment, nutritional assessment, ambulatory blood pressure monitoring, transthoracic echocardiography, and assessment of the quality of life. The sample size has been determined as 40 patients, who will be divided into two groups: control group (CG; n = 20) and intervention group (IG; n = 20). The CG will undergo conventional physiotherapy for 45 min, three times a week, up to 16 weeks, while the IG will be put on a cardiovascular rehabilitation program consisting of heating, aerobic exercise, and muscle strengthening for 45 min, three times a week, for 16 weeks. The primary endpoint will be functional capacity following a 6-min walk test (delta maxVO2) and morphofunctional echocardiographic variables (indexed left ventricular mass) before and after the intervention.
DISCUSSION: We expect to observe an improvement in cardiac structural and functional abnormalities in the IG, on echocardiography and biochemical examination, and that the improvement of these parameters after cardiovascular rehabilitation will have a favorable impact on the functional capacity and quality of life of patients after stroke.
TRIAL REGISTRATION: REBEC, RBR-4wk4b3. Registered on 19 September 2016.
Предметные рубрики MeSH
Activities of Daily LivingAtrial RemodelingBlood Pressure Monitoring, AmbulatoryBrain IschemiaCardiac RehabilitationEchocardiographyElectrocardiographyExerciseFemaleHumansMaleNutritional StatusOutcome Assessment, Health CareQuality of LifeRandomized Controlled Trials as TopicStroke RehabilitationVentricular Remodeling